Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients

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Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients

Condition or disease

Intervention/treatment

Phase

Warts

Drug: Imiquimod 5% cream

Phase 4

Detailed Description:

To evaluate the percentage of HIV+ subjects successfully treated with HAART, with total clearance (100%) of baseline external genital or perianal warts within 16 weeks of treatment with imiquimod 5% cream.

Subjects were treated with imiquimod (one sachet/20 cm2), three applications per week, for up to 16 weeks, or fewer in the case of total clearance of initial warts. At the visit at the end of treatment, a second scraping of the lesion area was carried out to determine the sub-type of HPV.

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Ages Eligible for Study:

18 Years to 69 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject able to understand and willing to give written informed consent.

Accepting to abstain from sexual intercourse when study drug is on the skin.

In case of a coexisting AIDS-defining illness, both this illness and any treatment being received for it must have been stable for the four weeks preceding enrolment in the trial.

If female and of childbearing potential, have negative urine pregnancy tests, and willing to use a medically acceptable method of contraception during the 16-week treatment period. Subjects were considered to be of childbearing potential unless the uterus or both ovaries had been removed or they were two or more years postmenopausal. For this study, the following were considered to be acceptable methods of contraception:

Surgical sterilization, defined as tubal ligation of the subject or a vasectomy of the subject's partner if that subject is in a monogamous heterosexual relationship (at the Investigator's discretion)

Oral, injectable, or implantable contraceptives

Condoms (with spermicide)

Diaphragm/cervical cap (with spermicide)

Intrauterine devices (IUDs)

Complete abstinence (at the Investigator's discretion)

Exclusion Criteria:

Women pregnant or lactating;

Treatment within four weeks prior to the Treatment Initiation Visit and throughout the entire study with:

Any genital wart therapy, or Immunomodulators

Systemic antiviral drugs other than acyclovir, valacyclovir, or famcyclovir and other than HAART